ENALAPRIL VIR 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

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Enalapril Vir20 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Enalapril Vir is and what it is used for
2. What you need to know before taking Enalapril Vir
3. How to take Enalapril Vir
4. Possible side effects
5. Storage of Enalapril Vir
6. Contents of the pack and further information

1. What Enalapril Vir is and what it is used for

Enalapril Vir belongs to a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril Vir is indicated for:

• Treating high blood pressure (hypertension).
• Treating heart failure (weakening of heart function). It can reduce the need for hospitalization and may help some patients live longer.
• Preventing signs of heart failure. Signs include: difficulty breathing, fatigue after mild physical activity such as walking, or swelling of the ankles and feet.

This medication works by widening your blood vessels. This reduces your blood pressure. Normally, the medication starts working within an hour, and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before the full effect on blood pressure is seen.

2. What you need to know before taking Enalapril Vir

Do not takeEnalapril Vir:

• If you are allergic to enalapril or any of the other components of this medication (listed in section 6).
• If you have been previously treated with a medication from the same group of drugs as enalapril (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing.
• If you have ever had swelling of the face, lips, mouth, tongue, or throat that caused difficulty swallowing or breathing (angioedema) for unknown reasons or due to hereditary factors.
• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is high.
• If you have diabetes or kidney problems and are being treated with a blood pressure medication that contains aliskiren.
• If you are pregnant for more than 3 months. (It is also best to avoid Enalapril Vir at the beginning of pregnancy - see section Pregnancy).

Do not take this medication if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril Vir

• If you have a heart problem.
• If you have a disease that affects the blood vessels in the brain.
• If you have blood disorders such as low or absent white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• If you have a liver problem.
• If you have a kidney problem (including kidney transplant). This may cause high levels of potassium in your blood, which can be serious. Your doctor may need to adjust your dose of Enalapril or monitor your potassium levels in your blood.
• If you are undergoing dialysis.
• If you have recently had severe vomiting or intense diarrhea
• If you are on a low-salt diet, taking potassium supplements, or taking medications that can increase potassium levels in your blood (such as potassium-sparing diuretics).
• If you are over 70 years old.
• If you have diabetes. You should monitor your blood sugar levels, as you may experience low blood sugar levels, especially during the first month of treatment. Your potassium levels in your blood may also be higher.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing. You should be aware that black patients have a higher risk of experiencing these types of reactions to ACE inhibitors.
• If you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:

−Racecadotril (a medication used to treat diarrhea),

−Medications used to prevent organ transplant rejection and for

cancer (e.g., temsirolimus, sirolimus, everolimus)

−Vildagliptin (a medication used to treat diabetes).

• If you have low blood pressure (you may notice dizziness or lightheadedness, especially when standing).
• If you have vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medications that suppress your immune system, or are taking the medications allopurinol or procainamide or any combination of these.
• If you are taking any of the following medications used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Enalapril Vir" and "Warnings and precautions").
• Other medications to reduce blood pressure, such as beta blockers, angiotensin receptor antagonists, or diuretics.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading "Do not take Enalapril Vir".

You should inform your doctor if you think you are pregnant (or might be). This medication is not recommended at the beginning of pregnancy and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this period.

You should be aware that this medication reduces blood pressure in black patients less effectively than in non-black patients.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take this medication.

If you are about to undergo a procedure

If you are about to undergo any of the following procedures, inform your doctor that you are taking Enalapril:

• Any surgery or if you are going to receive anesthetics (even at the dentist's office).
• A treatment to remove cholesterol from your blood called "LDL apheresis".
• A desensitization treatment to reduce the effect of an allergy to bee or wasp stings.

If any of the above situations apply to you, consult your doctor or dentist before starting the procedure.

Taking Enalapril Vir with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medications, including herbal treatments. This is because Enalapril may affect how other medications work, and other medications may affect how Enalapril works. Your doctor may need to adjust your dose and/or take other precautions.

In particular, inform your doctor or pharmacist if you are taking any of the following medications:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Enalapril Vir" and "Warnings and precautions").
• Other medications to reduce blood pressure, such as beta blockers, angiotensin receptor antagonists, or diuretics.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in your blood (such as trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to thin blood to prevent clots).
• Medications for diabetes (including oral antidiabetic medications and insulin).
• Lithium (a medication used to treat certain types of depression).
• Medications for depression called "tricyclic antidepressants".
• Medications for mental problems called "antipsychotics".
• Certain medications for cough and cold and weight loss medications that contain a substance called "sympathomimetic medication".
• Certain medications for pain or arthritis, including gold treatments
• non-steroidal anti-inflammatory medications, including COX-2 inhibitors (medications that reduce inflammation and may be used to help relieve pain).
• Aspirin (acetylsalicylic acid).
• Medications used to dissolve blood clots (thrombolytics).
• Alcohol.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take Enalapril.

Taking Enalapril Vir with food and drinks:

Food does not affect the absorption of Enalapril Vir.

Alcohol enhances the blood pressure-lowering effect of enalapril, so inform your doctor if you are consuming alcoholic beverages while taking this medication.

Pregnancy, breastfeeding, and fertility:

Consult your doctor or pharmacist before using a medication.

You should inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Enalapril Vir before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Enalapril Vir. Enalapril Vir is not recommended at the beginning of pregnancy and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this period.

Inform your doctor if you are breastfeeding or about to start breastfeeding. While taking Enalapril Vir, breastfeeding is not recommended in newborns (first few weeks after birth), especially in premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking Enalapril Vir compared to other treatments while breastfeeding.

Driving and using machines:

You may feel dizzy or drowsy while taking this medication. If this occurs, do not drive or use tools or machines.

Enalapril Vir contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Enalapril Vir

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• It is very important that you continue taking this medication for the duration prescribed by your doctor.
• Do not take more tablets than prescribed.

High blood pressure

• The usual initial dose is between 5 and 20 mg, taken once a day.
• Some patients may need a lower initial dose.
• The usual long-term dose is 20 mg taken once a day.
• The maximum long-term dose is 40 mg taken once a day.

Heart failure

• The usual initial dose is 2.5 mg, taken once a day.
• Your doctor will gradually increase this amount until the appropriate dose for you is reached.
• The usual long-term dose is 20 mg per day, taken in one or two doses.
• The maximum long-term dose is 40 mg per day, divided into two doses.

Patients with kidney problems

Your medication dose will change depending on how well your kidneys are functioning:

• Moderate kidney problems - 5 mg to 10 mg per day.
• Severe kidney problems - 2.5 mg per day.
• If you are undergoing dialysis - 2.5 mg per day. On days when you are not undergoing dialysis, your dose may change depending on how low your blood pressure is.

Elderly patients

Your doctor will decide the dose based on how well your kidneys are functioning.

Children

Experience with the use of Enalapril Vir in children with high blood pressure is limited. If the child can swallow tablets, the dose will be calculated based on the child's weight and blood pressure. The usual initial doses are:

• Between 20 kg and 50 kg - 2.5 mg per day.
• Over 50 kg - 5 mg per day.

The dose may be changed according to the child's needs:

• A maximum of 20 mg per day can be used in children who weigh between 20 kg and 50 kg.
• A maximum of 40 mg per day can be used in children who weigh over 50 kg.

This medication is not recommended in newborns (first few weeks after birth) or in children with kidney problems.

If you take more Enalapril Vir than you should

If you take more Enalapril Vir than you should, consult your doctor or go to the hospital immediately. Bring the medication package with you. The following effects may occur: dizziness or lightheadedness. This is due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20.

If you forget to take Enalapril Vir

• If you forget to take a tablet, do not take the missed dose.
• Take the next dose as usual.
• Do not take a double dose to make up for missed doses.

If you stop taking Enalapril Vir

Do not stop taking your medication unless your doctor tells you to do so.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following symptoms, stop taking Enalapril Vir and talk to your doctor immediately:

• Swelling of the face, lips, tongue, or throat that can cause difficulty swallowing or breathing.
• Swelling of your hands, feet, or ankles.
• If you develop a red rash on the skin with swelling (hives).

You should be aware that black patients have a higher risk of suffering from this type of reaction. If you experience any of the above reactions, stop taking Enalapril Vir and talk to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this happens, lying down can help. This is due to a decrease in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please talk to your doctor.

Other adverse effects include:

Very Common(may affect more than 1 in 10 people)

• Feeling of dizziness, weakness, or vomiting.
• Blurred vision.
• Cough.

Common(may affect up to 1 in 10 people)

• Low blood pressure, changes in heart rhythm, rapid heartbeats, chest pain, or chest tightness.
• Headache, fainting (syncope).
• Taste disturbance, difficulty breathing.
• Diarrhea or abdominal pain, rash.
• Fatigue, depression.
• Allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing.
• High levels of potassium in the blood, high levels of creatinine in the blood (usually both are detected in an analysis).

Uncommon(may affect up to 1 in 100 people)

• Sudden drop in blood pressure.
• Rapid and irregular heartbeats (palpitations).
• Myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, even those with alterations in heart or brain blood flow).
• Anemia (including aplastic and hemolytic anemia).
• Stroke (possibly due to very low blood pressure in high-risk patients).
• Confusion, drowsiness, or inability to sleep, nervousness.
• Feeling of itching or numbness in the skin.
• Dizziness.
• Noises in the ears (tinnitus).
• Rhinorrhea, sore throat, or hoarseness.
• Asthma.
• Slow movement of food through the intestine, pancreatitis.
• Vomiting, indigestion, constipation, anorexia.
• Irritated stomach (gastric irritation), dry mouth, ulcer, reduced kidney function, kidney failure.
• Increased sweating.
• Itching or hives.
• Hair loss.
• Muscle cramps, flushing, indisposition (general malaise), elevated temperature (fever), impotence.
• High levels of protein in the urine (determined in an analysis).
• Low levels of sugar or sodium in the blood, high levels of urea in the blood (all determined in a blood test).

Rare(may affect up to 1 in 1,000 people)

• "Raynaud's phenomenon" in which your hands and feet can become very cold and white due to low blood flow.
• Changes in blood values such as a lower number of white or red blood cells, lower hemoglobin, lower platelet count in the blood.
• Bone marrow depression.
• Autoimmune diseases.
• Sleep disturbances or sleep problems.
• Pulmonary infiltrates.
• Nasal inflammation.
• Pneumonia.
• Inflammation of the cheeks, gums, tongue, lips, throat.
• Reduced amount of urine produced.
• Erythema multiforme.
• "Stevens-Johnson syndrome", a severe skin disorder in which you have red and scaly skin, ulcers with blisters or open sores, or peeling of the top layer of skin from the underlying layers.
• Liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin (determined in an analysis).
• Enlargement of the breasts in men.

Very Rare(may affect up to 1 in 10,000 people)

• Swelling in the intestine (intestinal angioedema).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Enalapril Vir

Keep this medicine out of the sight and reach of children.

Store in the original package. Store protected from moisture.

Expiry Date:

Do not use this medicine after the expiry date stated on the package. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Enalapril Vir

The active ingredient is Enalapril in the form of maleate. Each tablet contains 20 mg of Enalapril.

The other ingredients (excipients) are: sodium bicarbonate (sodium hydrogen carbonate), lactose, cornstarch, sodium carboxymethylcellulose (type A) (derived from potato starch), magnesium stearate.

Appearance of the Product and Package Contents

Enalapril Vir 20 mg is presented in the form of tablets. Each package contains 28 tablets. The tablets are round, white, and scored.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Date of the Last Revision of this Prospectus: October 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es